Mehul Panchal
Principal Consultant
16+ years QC microbiology & aseptic processing
HEPA filtration: particles are capturedUnidirectional airflowCritical zone
Your partner in compliance
GMP technical consultation, qualification solutions and training
Providing cleanroom qualification for pharmaceutical and semiconductor industries, equipment qualification and CSV, GMP consultation, mock audits, and robust contamination control strategies.
Regulatory audits faced and defended
Hands-on experience facing inspections from global regulators, built into every protocol we write.
- USFDAU.S. Food and Drug AdministrationAudit faced United States
- EMAEuropean Medicines AgencyAudit faced European Union
- INVIMAInstituto Nacional de Vigilancia de Medicamentos y AlimentosAudit faced Colombia
Work aligned with
- Cleanroom classificationISO 14644-1
Classifies air cleanliness by the concentration of airborne particles.
- Cleanroom test methodsISO 14644-3
Test methods for airflow, pressure, filter leaks, recovery and containment.
- United StatesUSFDA cGMP
21 CFR Parts 210 and 211 for drug manufacturing, and Part 11 for electronic records.
- European UnionEU GMP
EudraLex Volume 4, including Annex 1 for sterile medicinal products.
- InternationalPIC/S GMP
The GMP guide shared by inspectorates of the Pharmaceutical Inspection Co-operation Scheme.
- IndiaSchedule M
GMP requirements under the Drugs and Cosmetics Act, 1940 and its Rules.
Where microbiology expertise meets rigorous GMP
Based in Ahmedabad, SteriQual Solutions Pvt. Ltd. provides specialized technical consulting for pharmaceutical, semiconductor and controlled cleanroom environments.
We leverage more than 16 years of industrial QC microbiology experience to design robust facility qualifications and audit-ready contamination control workflows, bridging the gap between complex regulatory mandates and practical everyday laboratory operations.
We partner closely with your team to eliminate compliance gaps, offering tailored consulting, robust contamination control strategies, and training designed to withstand strict global regulatory inspections and protect patient safety.
At a glanceExpertise behind every project
- QC microbiology
- 16+ years, industrial and aseptic processing
- Instrumentation
- 12 years, pharmaceutical equipment engineering
- Audits faced
- USFDA EMA INVIMA
Specialized services for high‑precision sectors
From equipment qualification including CSV to sterile and depyrogenated laboratory consumables, we deliver tailored compliance and contamination control strategies for your workflows.
Comprehensive compliance, risk management and validation frameworks for sterile and non-sterile drug manufacturing facilities.
- Contamination Control Strategy (CCS)
- Microbial failure investigations
- Aseptic Processing Simulation (APS) troubleshooting
- Water system & area qualification
- Equipment qualification including CSV
- Mock auditing & regulatory readiness
Practical compliance strategies built for your critical facility needs
We provide highly tailored solutions for any compliance activity, aligning our validation and contamination control strategies with your unique facility workflows and regulatory requirements.
Collaborate with usMicrobiology-driven
Bringing 16+ years of core industrial QC expertise to identify, isolate and mitigate cleanroom contamination vectors effectively.
Audit-ready blueprints
Building rigorous, technically sound validation protocols and computer system validation frameworks shaped around global regulatory expectations.
Data-reliability focused
Delivering meticulous, traceably documented procedures and specialized training structures that robustly eliminate laboratory subjectivity and human error.
The specialists you work with
Full profilesDharmesh Prajapati
Consultant, Instrumentation & Equipment Compliance
12 years Pharmaceutical equipment engineering
Ready to build an audit-ready system?
Let’s talk about your project and find the perfect solution for your facility.